Myelodysplastic SyndromesPhase 2NCT06594965
A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
A Phase 2 study testing HS-20106 in people with Myelodysplastic Syndromes and Anemia, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Anemia, MDS
- What is being tested?
- HS-20106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MDS according to World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease（IPSS-R ≤ 3.5）.
- < 5% blasts in bone marrow and < 1% blasts in peripheral blood.
- Each cohort is defined as:
- Cohort 1： In NTD participants, having received no red blood cell (RBC) transfusions within 16 weeks Hgb concentration between 60 and 100g/L.
- Cohort 2： In LTB participants, having received an average of < 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks/2) Hgb concentration between 60 and 100 g/L.
- In HTB participants, having received an average of ≥ 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks/2) Hgb concentration between 60 and 100 g/L.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.
- Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.
Who cannot join
- Chromosome 5q deletion, del (5q).
- Anemia caused by other reasons, such as iron deficiency anemia, megaloblastic anemia, aplastic anemia, renal anemia or blood loss.
- Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
- Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
- Treatment within 4 weeks prior to C1D1 with:
- 1) Erythropoiesis stimulating agent (ESA) OR 2) Granulocyte colony-stimulating factor (G-CSF) OR 3) Granulocyte-macrophage colony-stimulating factor (GM-CSF) 6. Iron chelation therapy if initiated within 8 weeks prior to C1D1. 7. Vitamin B12 therapy if initiated within 8 weeks prior to C1D1. 8. Treatment with another investigational drug or device or approved therapy for investigational use < or = 4 weeks prior to C1D1, or if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.
- 9. Peripheral blood white blood cell count >13.0 x 109/L. 10. Neutrophil count < 1.0 x 109/L. 11. Platelet count > 450 x 109/L or < 30 x 109/L. 12. Transferrin saturation < 15%. 13. Ferritin < 15 μg/L. 14. Folate < 4.5 nmol/L (< 2.0 ng/mL). 15. Vitamin B12 < 148 pmol/L (< 200 pg/mL). 16. Estimated glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
- 17. Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology and Blood Diseases Hospital
Tianjin, Tianjin Municipality
About this study
Official title: Phase II Study on the Efficacy, Safety, and Pharmacokinetics of HS-20106 in Patients With IPSS-R Very Low-risk, Low-risk, or Moderate-risk Myelodysplastic Syndrome (MDS) Anemia
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS.
Read the detailed description
Anemia is considered to be one of the most prevalent cytopenias in patients who have myelodysplastic syndromes, an umbrella term used to describe disorders relating to the ineffective production of red blood cells, white blood cells, and/or platelets. The goal of this study is to assess the efficacy, safety and PK of HS-20106 on anemia in Chinese patients with very low, low or intermediate risk MDS. Eligible subjects will be treated with HS-20106. Patients should be treated for at least 24 weeks in the core treatment period to assess their response to treatment.
- Conditions
- Myelodysplastic Syndromes, Anemia, MDS, Bone Marrow Disease
- Being tested
- HS-20106
- Keywords
- MDS, HS-20106, KER-050, fusion protein, TGF-β
- Medical subject headings
- Myelodysplastic Syndromes, Anemia, Bone Marrow Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20106Drug
HS-20106 administered subcutaneously every 4 weeks for up to 6 cycles. Eligible participants may be able to continue to receive subcutaneously administered HS-20106 after completing 6 cycles in the extended treatment period.
| Study group | Role | What they receive |
|---|---|---|
| HS-20106 Cohort 1 | Experimental | Part A: Non-transfusion dependent population Receives: Drug: HS-20106 |
| HS-20106 Cohort 2 | Experimental | Part A: Transfusion-Dependent Population（low-transfusion burden (LTB) and high-transfusion burden (HTB)） Receives: Drug: HS-20106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve modified 2006 International Working Group (IWG)Hematologic Improvement-Erythroid (HI-E) response
- In NTD and LTB participants, response is defined as a mean hemoglobin (Hgb) increase of ≥ 15 g/L from Baseline during any consecutive 8-week period during the treatment period (in the absence of RBC transfusions)
- In HTB participants, response is defined as a reduction by ≥ 4 units of RBCs transfused during any consecutive 8-week period on study compared with Baseline
Measured: Week 1 through Week 24
Secondary outcomes (11)
HI-E Duration
the maximum duration of meeting the HI-E criteria for a subject who achieved HI-E.
Measured: Throughout the study period, assessed up to 48 weeks.
Time to HI-E
the time from the first dose of study drug to the first achievement of HI-E.
Measured: Week 1 through Week 24
Proportion of participants with RBC-TI ≥ 8 Weeks（cohort 2 only）
the proportion of participants who did not require RBC transfusion for at least 1 consecutive 8-week period.
Measured: Week 1 through Week 24
Duration of TI response
the longest duration of response for participants who achieved RBC-TI of ≥ 8 weeks during the treatment period
Measured: Throughout the study period, assessed up to 48 weeks.
Time to RBC-TI ≥ 8 weeks
the time from the first dose of study drug to the first achievement of RBC-TI ≥ 8 weeks.
Measured: Week 1 through Week 24
The proportion of participants with progression to intermediate-risk (IPSS-R score > 3.5) and higher MDS or AML.
Percentage of participants progressing to intermediate-risk (IPSS-R score > 3.5) or higher MDS or AML throughout the course of the study
Measured: Week 1 through Week 24
Time to progression to intermediate-risk (IPSS-R score > 3.5) or higher MDS or AML.
Time to progression was defined as the time between the first dose date and the first diagnosis of progression.
Measured: Week 1 through Week 24
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Type, frequency, severity of AEs and relationship of AEs to HS-20106
Measured: Throughout the study period, assessed up to 48 weeks.
Pharmacokinetic- AUC
Pharmacokinetics of HS-20106
Measured: Throughout the study period, assessed up to 48 weeks.
Pharmacokinetic- Cmax
Maximum plasma concentration of drug
Measured: Throughout the study period, assessed up to 48 weeks.
Antidrug antibodies (ADA)
Frequency of antidrug antibodies and effects on efficacy, safety or PK
Measured: Throughout the study period, assessed up to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594965
- Sponsor's protocol ID
- HS-20106-201
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on the Efficacy, Safety, and Pharmacokinetics of HS-20106 in Patients With IPSS-R Very Low-risk, Low-risk, or Moderate-risk Myelodysplastic Syndrome (MDS) Anemia
- ClinicalTrials.gov ID
- NCT06594965
- Acronym / sponsor ID
- HS-20106-201
- Conditions
- Myelodysplastic Syndromes, Anemia, MDS, Bone Marrow Disease
- Keywords
- MDS, HS-20106, KER-050, fusion protein, TGF-β
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS.
Detailed description
Anemia is considered to be one of the most prevalent cytopenias in patients who have myelodysplastic syndromes, an umbrella term used to describe disorders relating to the ineffective production of red blood cells, white blood cells, and/or platelets. The goal of this study is to assess the efficacy, safety and PK of HS-20106 on anemia in Chinese patients with very low, low or intermediate risk MDS. Eligible subjects will be treated with HS-20106. Patients should be treated for at least 24 weeks in the core treatment period to assess their response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20106 Cohort 1 | Experimental | Drug: HS-20106Part A: Non-transfusion dependent population |
| HS-20106 Cohort 2 | Experimental | Drug: HS-20106Part A: Transfusion-Dependent Population（low-transfusion burden (LTB) and high-transfusion burden (HTB)） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of MDS according to World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease（IPSS-R ≤ 3.5）.
- < 5% blasts in bone marrow and < 1% blasts in peripheral blood.
- Each cohort is defined as:
- Cohort 1： In NTD participants, having received no red blood cell (RBC) transfusions within 16 weeks Hgb concentration between 60 and 100g/L.
- Cohort 2： In LTB participants, having received an average of < 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks/2) Hgb concentration between 60 and 100 g/L.
Key exclusion criteria (8 listed)
- Chromosome 5q deletion, del (5q).
- Anemia caused by other reasons, such as iron deficiency anemia, megaloblastic anemia, aplastic anemia, renal anemia or blood loss.
- Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
- Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
- Treatment within 4 weeks prior to C1D1 with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20106HS-20106 administered subcutaneously every 4 weeks for up to 6 cycles. Eligible participants may be able to continue to receive subcutaneously administered HS-20106 after completing 6 cycles in the extended treatment period. | Drug | HS-20106 Cohort 1, HS-20106 Cohort 2 |
Primary outcome
Proportion of participants who achieve modified 2006 International Working Group (IWG)Hematologic Improvement-Erythroid (HI-E) response
Time frame: Week 1 through Week 24
* In NTD and LTB participants, response is defined as a mean hemoglobin (Hgb) increase of ≥ 15 g/L from Baseline during any consecutive 8-week period during the treatment period (in the absence of RBC transfusions) * In HTB participants, response is defined as a reduction by ≥ 4 units of RBCs transfused during any consecutive 8-week period on study compared with Baseline
11 secondary outcomes
HI-E Duration
Time frame: Throughout the study period, assessed up to 48 weeks.
Time to HI-E
Time frame: Week 1 through Week 24
Proportion of participants with RBC-TI ≥ 8 Weeks（cohort 2 only）
Time frame: Week 1 through Week 24
Duration of TI response
Time frame: Throughout the study period, assessed up to 48 weeks.
Time to RBC-TI ≥ 8 weeks
Time frame: Week 1 through Week 24
The proportion of participants with progression to intermediate-risk (IPSS-R score > 3.5) and higher MDS or AML.
Time frame: Week 1 through Week 24
Time to progression to intermediate-risk (IPSS-R score > 3.5) or higher MDS or AML.
Time frame: Week 1 through Week 24
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Throughout the study period, assessed up to 48 weeks.
Pharmacokinetic- AUC
Time frame: Throughout the study period, assessed up to 48 weeks.
Pharmacokinetic- Cmax
Time frame: Throughout the study period, assessed up to 48 weeks.
Antidrug antibodies (ADA)
Time frame: Throughout the study period, assessed up to 48 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HS-20106 in people with Myelodysplastic Syndromes and Anemia, run by Hansoh BioMedical R&D Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhijian Xiao, PhD ((0086)022-23909184, xiaozj_mds026@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who achieve modified 2006 International Working Group (IWG)Hematologic Improvement-Erythroid (HI-E) response (time frame: Week 1 through Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.